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Early EUS-guided celiac plexus neurolysis versus opioids for the treatment of pain in pancreatic carcinoma

Early EUS-guided celiac plexus neurolysis versus opioids for the treatment of pain in pancreatic carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28425
Enrollment
120
Registered
2007-05-30
Start date
2006-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer, pain, opioids, analgesic therapy, celiac plexus neurolysis, endosonography pancreascarcinoom, morfine, analgetica, plexus coeliacus blokkade, endo-echo

Interventions

Patients will be randomised according to two treatment algorithms. The first “conventional” type treatment algorithms consists of increasing dosages of transdermal fentanyl patches. In this algorithm,

Sponsors

A.Voorburg MD, gastroenterologist. Academical Medical Center Amsterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cytological or histological proven irresectable pancreatic carcinoma; 2. Chronic pain unresponsive to non-opioid analgesic drugs and low dose fentanyl (Durogesic®) transdermal patches (VAS score >3 (figure 2)while using fentanyl transdermal patches maximum 50 ìg/h, 1 patch per 3 days); 3. Age above 18 years; 4. Karnovsky score >30 % (see table3)

Exclusion criteria

Exclusion criteria: 1. Previous celiac plexus blockade; 2. Use of opioids; 3. Refusal to sign informed co

Design outcomes

Primary

MeasureTime frame
Quality of Adjusted Life Years (QALYs) will be the primary outcome parameter. This is a composite endpoint linking survival and quality of life, i.e. the number of quality adjusted life years. These are based on biweekly assessments of health status with the EQ-5D questionnaire. The utility of each observed health score profile on the EQ-5D will be derived from previous research in which the time trade off based elicitation technique during interviews with adults from the general population has been applied.

Secondary

MeasureTime frame
1. Health-related quality of life (EORTC-QLQ-C30)(see table 2) 2. Survival 3. Opioid requirement 4. Health status (EQ-5D)(table 1 and figure 3) 5. Adverse effects 6. Costs

Contacts

Public ContactA. M.C.J. Voorburg
a.m.voorburg@amc.uva.nl+31 205668712

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)